Which amendment in 1962 required proof of drug safety?

• A. Harrison Narcotic Act
• B. Kefauver Harris Amendment
• C. Federal Food, Drug, and Cosmetic Act
• D. Schedule II medications

Answer: (B)

The main idea is that after a major drug tragedy, regulation shifted to require solid evidence of a drug’s safety and effectiveness before it can be marketed. The Kefauver-Harris Amendment of 1962 established that requirement, mandating substantial evidence from well-controlled studies to prove both safety and efficacy for new drug approvals. It strengthened the FDA’s oversight, introduced good manufacturing practices, and added protections for clinical trials such as informed consent and adverse-event reporting. This amendment didn't apply to narcotics regulation from earlier acts, nor did the 1938 act require efficacy proof (it focused on safety), and Schedule II refers to a drug classification, not an amendment.